21CFR Part 11 Instrument Control Software for Distek Model 2100C, 6100, 6300, and 4300. Full 21CFR Part 11 Compliance Requires Customer Participation. Software Provides Total Instrument Control and Monitoring Including Remote Access._1696359
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Distek Cipher 21 CFR Part 11 Instrument Control Software – Full Compliance & Monitoring

The Distek Cipher 21 CFR Part 11 Instrument Control Software is a versatile Windows-based application that provides complete instrument control and monitoring for Distek dissolution testers, autosamplers, and tablet disintegration testers. Designed to ensure full Data Integrity and 21 CFR Part 11 compliance when paired with properly developed customer policies, Cipher allows flexible customization of security and workflow settings.

Product Features

  • Full 21 CFR Part 11 and Data Integrity compliance for Distek instruments
  • Electronic signatures (eSignatures) for methods and reports, with customizable signatory levels
  • Method Wizard guides users through method creation and optimization
  • LIMS compatible – automatic export of results in ASCII format
  • Instrument networking – monitor and control instruments remotely from client workstations
  • Audit Trail – tracks events, system changes, and method updates with timestamps and user info
  • Compendia Alerts – notifies users if readings fall outside acceptable ranges
  • Supports local or network installation for flexible deployment

Benefits

  • Ensures regulatory compliance for laboratories using Distek instruments
  • Enhances data integrity and traceability with secure audit trails
  • Flexible software customization to meet company policies and workflows
  • Remote access and monitoring improve efficiency in multi-instrument labs

Why Choose the Distek Cipher 21 CFR Part 11 Software Instrument Control Software – Full Compliance & Monitoring?

This software provides total control and monitoring of Distek dissolution, autosampler, and disintegration instruments, ensuring full compliance with 21 CFR Part 11 and Data Integrity standards. Its network capabilities, eSignatures, and audit trail functionality make it an ideal solution for regulated laboratories.

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